ATTENTION! Legacy Validation Method

Please note this article describes the legacy validation method. Click here for information on Qualio's modern validation approach.

You've just had your kick-off call with the Customer Success team and they just threw a lot of information at you when it comes to your first step of the onboarding process - Validation of Qualio!

By now, you should have received your validation pack that has all the documentation you'll need in order to complete the validation of your new Qualio instance. The validation pack includes the following information:

  • Instructions/Guidance on how to complete (PDF)

  • Validation Documents (folder)
    - Documents, Reports, and Training - main documents, required
    - SSO Addendum - optional, if planning to utilize
    - Product Development Addendum - optional, if planning to utilize
    - Supplier Management Addendum - optional, if planning to utilize

  • Supporting Documents (folder)
    - Data Security Policy
    - Software Development Policy
    - Disaster Recovery Policy
    - Use of Electronic Signatures SOP Guidelines
    - Validation Change Control
    - Vendor Supplier Questionnaire

NOTE: All documentation provided in this packet is fully editable by your team. You can make any changes you wish, but you may also choose to make no changes - completely up to you!

If you do choose to leave these documents as-is, we provide the basic information which needs to be updated by your team within the PDF that's found in the validation pack:

As you can see, some documents only require an update to the header of those documents. Here's an example of the areas that should be updated in the header:

For information on where the Document ID and Version are found, see our article on Validation FAQ

Some documents, such as the Validation Plan and Risk Assessment, have references to documents that you may or may not already have in place.

If you do not have these documents created already - no problem! You can simply update the underlined area to a more generalized statement. Here's an example below:

Original Validation Pack Validation Plan:

Updated to:

These procedures can be created at a later time and do not need to be in place prior to the validation of Qualio.

If you DO have these documents already, you can reference your current procedure number in this spot.

It's recommended that documents are completed in order (1 through 6).

Helpful References:

Validation FAQ - What do I do when I'm done? Who is the performer/verifier?

How to Perform the UAT

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